miebo

Generic: perfluorohexyloctane

Labeler: bausch & lomb incorporated
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name miebo
Generic Name perfluorohexyloctane
Labeler bausch & lomb incorporated
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

perfluorohexyloctane 1 mg/mg

Manufacturer
Bausch & Lomb Incorporated

Identifiers & Regulatory

Product NDC 24208-377
Product ID 24208-377_4cb37a53-376f-ef57-e063-6294a90a5bf8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216675
Listing Expiration 2027-12-31
Marketing Start 2023-05-18

Pharmacologic Class

Established (EPC)
semifluorinated alkane [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24208377
Hyphenated Format 24208-377

Supplemental Identifiers

UPC
0324208377055
UNII
7VYX4ELWQM
NUI
N0000194071 N0000194072

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name miebo (source: ndc)
Generic Name perfluorohexyloctane (source: ndc)
Application Number NDA216675 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mg
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (24208-377-01) / 3 mg in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (24208-377-05) / 3 mg in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (24208-377-06) / 1.6 mg in 1 BOTTLE
source: ndc

Packages (3)

24208-377-01 1 BOTTLE in 1 CARTON (24208-377-01) / 3 mg in 1 BOTTLE 24208-377-05 1 BOTTLE in 1 CARTON (24208-377-05) / 3 mg in 1 BOTTLE 24208-377-06 1 BOTTLE in 1 CARTON (24208-377-06) / 1.6 mg in 1 BOTTLE

Ingredients (1)

perfluorohexyloctane (1 mg/mg)

Linked Drug Pages (1)

MIEBO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4cb37a53-376f-ef57-e063-6294a90a5bf8", "openfda": {"nui": ["N0000194071", "N0000194072"], "upc": ["0324208377055"], "unii": ["7VYX4ELWQM"], "spl_set_id": ["6b283c02-7df4-4c00-951b-555cddffe77c"], "pharm_class_epc": ["Semifluorinated Alkane [EPC]"], "manufacturer_name": ["Bausch & Lomb Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE in 1 CARTON (24208-377-01)  / 3 mg in 1 BOTTLE", "package_ndc": "24208-377-01", "marketing_start_date": "20230518"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (24208-377-05)  / 3 mg in 1 BOTTLE", "package_ndc": "24208-377-05", "marketing_start_date": "20230518"}, {"sample": true, "description": "1 BOTTLE in 1 CARTON (24208-377-06)  / 1.6 mg in 1 BOTTLE", "package_ndc": "24208-377-06", "marketing_start_date": "20240719"}], "brand_name": "MIEBO", "product_id": "24208-377_4cb37a53-376f-ef57-e063-6294a90a5bf8", "dosage_form": "SOLUTION", "pharm_class": ["Semifluorinated Alkane [EPC]", "Semifluorinated Alkane [EXT]"], "product_ndc": "24208-377", "generic_name": "Perfluorohexyloctane", "labeler_name": "Bausch & Lomb Incorporated", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MIEBO", "active_ingredients": [{"name": "PERFLUOROHEXYLOCTANE", "strength": "1 mg/mg"}], "application_number": "NDA216675", "marketing_category": "NDA", "marketing_start_date": "20230518", "listing_expiration_date": "20271231"}